Kornimate/medical-research-clean huggingface dataset:
comparative trial of disulfiram, naltrexone and acamprosate in the treatment of alcohol dependence

Conditions: Alcohol Dependence

Summary: the aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy.

context alcoholism is common clinical problem and its treatment has no standard and is controversy. different pharmacotherapy's, acamporsate, nalterxone and disulfiram have shown to improve the drinking outcomes, but there is no randomized comparative studies on the effects of these three medications. objectives the aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy. design and setting randomized, open label, multicentre naturalistic study, 12 week continuous medication followed by targeted medication up to 52weeks and 67 week follow up on voluntary treatment seeking alcohol dependent outpatients. participants 243 alcohol dependent adults. intervention subjects were randomized 1:1:1 to receive naltrexone, acamprosate or disulfiram, 50 mg, 1998 mg or 200 mg correspondingly per day. the patients were met weekly in first month, then after 3, 6 and 12 months.

Eligibility criteria:
inclusion criteria: * alcohol dependence (icd-10) exclusion criteria: * clinically significant symptoms of alcohol withdrawal * significant recently diagnosed psychiatric disease (psychosis, personality disorder or suicidal tendency that appeared during the initial interview) * current psychiatric disease demanding special treatment or medication including dsm-iv determined drug dependence other than alcohol or nicotine dependence * current use of any opioids within four weeks before screening * significant brain, thyroid, kidney, uncompensated heart disease, or clinically significant liver disease (cirrhosis, aqlcoholic hepatitis or alat \> 200) * pregnancy, nursing, or women refused to use a reliable method for birth control

Keywords: alcoholism dependence randomization effect disulfiram naltrexone acamprosate
effects of pgi2 analogue use on the development of chronic allograft nephropathy

Conditions: Chronic Allograft Nephropathy

Summary: the purpose of this study is to evaluate the effect of prostaglandin i2 analogue use on the development of chronic allograft nephropathy and changes in allograft function in prevalent renal transplant recipients


Eligibility criteria:
inclusion criteria: * prevalent renal transplant recipients 2 years after transplantation * no history of acute rejection * stable renal function exclusion criteria: * history of biopsy-proven chronic allograft nephropathy * history of biopsy-proven cni nephrotoxicity * history of biopsy-proven or clinical acute rejection * unstable trough level of cni or extremely low level of cni * bleeding tendency(+) * pregnancy or pregnant-willing * anticoagulation(+) * antiplatelet agent (+) * significant comorbidity(+): acute coronary syndrome, pneumonia
therapeutic orientation test in thrombotic microangiopathy

Conditions: Thrombotic Micro-angiopathy

Summary: haemolytic and uraemic syndrome (hus) is a serious disease requiring rapid diagnosis and management. the atypical hus diagnosis has been greatly improved by anti-cs antibody (eculizumab) wich block alternative complement pathway activation. to rise treatment success, eculizumab introduction should be as early as possible. in some secondary hus (infection, drugs...) complement is also involved as "second-hit". to date, there is no tool to confirm complement involvement in a hus at diagnosis stage. this study suggest to evaluate a therapeutic orientation test, in order to determine the complement implication in hus diagnosis. the test evaluates the complement deposits on endothelial cell surface in vitro, compared to a normal human serum. in order to determine the test performance, first the positive or negative results will be compared to the hus clinical evolution, treated or not by the clinician with eculizumab. second, the test results will be compared to the presence of alternative complement pathway regulation abnormalities.


Eligibility criteria:
inclusion criteria: tma with: * mechanic haemolytic anemia, undetectable haptoglobin, ldh\>1.5\*lns * thrombopenia * acute kidney injury tma on native kidney or in post-transplantation. exclusion criteria: * divc patients * plasma exchange during 1 month before sample collection * treatment by eculizumab before sample collection * no consent * not beneficiary of a social security * pregnancy or breastfeeding * patient under guardianship

Keywords: nephrology complement thrombotic micro-angiopathy diagnostic haemolytic and uraemic syndrome
transplantlines food and nutrition biobank and cohort study (txl-fn)

Conditions: Transplantation Infection; Renal Transplant Donor of Left Kidney

Summary: short-term (1-year) results of renal transplantation are now excellent (over 95%). long-term (10-year and longer) results are, however, still disappointing. where most research has focused on immunosuppression and infections, the investigators hypothesize that due to poor homeostatic capacity and necessary use of immunosuppressive and other drugs, renal transplant recipients are much more susceptible to poor dietary habits and exposure to potentially toxic contaminants than people of the general population, and that this contributes to accelerated function loss of the graft and excess risk of premature mortality, both contributing to poor long-term results. this study is a biobank and cohort study which investigates this hypothesis.

short-term (1-year) results of renal transplantation are now excellent (over 95%). long-term (10-year and longer) results are, however, still disappointing. where most research has focused on immunosuppression and infections, the investigators hypothesize that due to poor homeostatic capacity and necessary use of immunosuppressive and other drugs, renal transplant recipients are much more susceptible to poor dietary habits and exposure to potentially toxic contaminants than people of the general population, and that this contributes to accelerated function loss of the graft and excess risk of premature mortality, both contributing to poor long-term results. to investigate one part of this overarching hypothesis, the investigators wrote a project on around the specific topic of the relation between dietary acid load, ammoniagenesis and its potential influence on blood pressure. the investigators used this project to build a biobank and cohort in which they can test additional hypotheses on the relation between diet, contaminants and development of graft failure and the occurrence of mortality. the investigators also included 300 healthy controls to compare diet, contaminant exposure and biomarkers with the renal transplant recipients.

Eligibility criteria:
inclusion criteria: more than one year after transplantation, prognosis \> 1 year, stable outpatients situation - exclusion criteria: acute illnesses, fever, current hospitalisation -
long-term persistence study to assess a booster dose of gsk biologicals' hib-menc

Conditions: Haemophilus Influenzae Type b; Neisseria Meningitidis

Summary: this protocol posting deals with objectives \& outcome measures of the extension phase at months 18, 30, 42, 54 and 66 post booster. the objectives \& outcome measures of the primary phase are presented in a separate protocol posting (nct number = nct00352963). the objectives \& outcome measures of the booster phase/study are presented in a separate protocol posting (nct number =nct00323050). the purpose of this study is to evaluate the persistence of meningococcal serogroup c and hib antibodies on a yearly basis for a period of 5.5 years after booster vaccination. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

this multicenter study is open. no vaccine will be administered during this persistence phase of the study. the subjects were randomized in the primary vaccination study 217744/097 (dtpa-hbv-ipv-097) and will not be further randomized in this study. the study has 3 groups with meningitec™ primed group as control. the protocol was amended to allow for enrollment of subjects of the meningitec™ primed control group who were boosted with meningitec™ after the end of the booster study as per new local reccommendation in spain.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * a male or female in their third year of life at the time of the study initiation for the subjects who enter the study at visit 1. the subjects who enter the study at visit 2 should be in their fourth year of life at the time of the study initiation. * written informed consent obtained from the parent or guardian of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * having completed the booster vaccination study hib-menc-tt-010 bst:dtpa-hbv-ipv-097 (nct=00323050). * subjects who are part of the meningitec™ control group and who were not enrolled at visit 1 can be enrolled at visit 2 if they have completed the booster vaccination study hib-menc-tt-010 bst:dtpa-hbv-ipv-097 (nct=00323050) and if they have received a fourth dose of meningitec™ in their second year of life, after the booster study hib-menc-tt-010 bst:dtpa-hbv-ipv-097 (nct=00323050) exclusion criteria: * previous administration of a booster dose of hib or meningococcal serogroup c except booster study vaccines during the study hib-menc-tt-010 bst:dtpa-hbv-ipv-097. subjects who received a 4th dose of meningitec™ should be included in the study. * history of h. influenzae type b, meningococcal serogroup c diseases.

Keywords: h.influenzae type b disease
influence of obstructive sleep apnea on metabolism and weight loss in obese individuals

Conditions: Obstructive Sleep Apnea; Obesity

Summary: obstructive sleep apnea (osa) can impars body weight reduction by changes in body composition and energy expenditure. the objective of this study is to evaluate the influence of osa in energy metabolism and body mass loss in obese subjects. ninety obese volunteers of both genders, 45 diagnosed with osa and 45 without osa, will be submitted to a dietary intervention of one months. volunteers will be distributed into four groups: obese osa ptn with moderate protein diet (1.6 g / kg protein / day), obese osa cho diet (0.8 g / kg protein / day) with standard composition diet, obese nsaos ptn diet moderate in protein and cho nsaos obese standard diet. all groups will be instructed to perform a restricted energy diet (less 30% of daily energy expenditure). at baseline and one month after the beginning of the program the following evaluations will be conducted: total energy expenditure measured by doubly labeled water method, resting energy expenditure and thermic effect of food by calorimetry, polysomnography analysis, body composition by pletysmography, food consumption by three days of food diary, blood collection for analysis of lipid profile, visceral proteins, hormones related to control of body weight and inflammation. as hypothesis we believe that apneic obese individuals have greater difficult in weight loss and loss more free fat mass than the obese no apneic and that diets with more protein can contribute to greater weight loss, better body composition and energy expenditure in these population.


Eligibility criteria:
inclusion criteria: * body mass index between 30 and 40 kg/m2; * obstructive sleep apnea mild or severe; * sedentary. exclusion criteria: * intake of any drug that interfere on metabolism such for thyroid or to lose weight; * be engaged in other treatment for sleep apnea or obesity; * present another sleep disorder; * being shift work; * present any kind of kidney disease.

Keywords: obstructive sleep apnea obesity diet energy expenditure
low intensity 'blue light' treatment of seasonal affective disorder

Conditions: Seasonal Affective Disorder

Summary: one of the most frequently investigated hypothesis of the pathophysiology underlying seasonal affective disorder(sad) or so called winter depression is a disturbance of circadian rhythms. since the circadian system is especially sensitive for the blue portion of the light spectrum, a new light therapy device with more blue light (blue enriched polychromatic light) was tested for its efficacy to treat sad. in chronobiological terms this light is hypothesized to be more potent in inducing non-visual effects. in the present study fluorescent tubes that emit a high portion of short wavelength light on top of the normal wavelengths are tested for its superiority in treating sad. this blue-enriched light (colour temperature 17000 ºk) is compared to standard light treatment (5000 º k) in sad patients.,in a earlier study it was shown that the therapeutic effect of blue enriched light were equal to standard light treatment using light in both conditions with an intensity of 10 000 lux. in the present study, blue enriched light with an intensity of 750 lux was used, because of the possible saturation effect in the former study. the investigators hypothesise that blue- enriched light with a low intensity improve the therapeutic effects of light treatment leading to a higher response or the same response in a shorter time schedule compared to standard light treatment.


Eligibility criteria:
inclusion criteria: * age 18-65 * diagnose of seasonal affective disorder, winter type according to dsm-iv sigh sad rating higher then or equal to 18 on day 1 * no other treatments for mood disorder during the study * stay in the netherlands during the study exclusion criteria: * other axis-i disorders according to the dsm-iv * acute suicide risk * use of psychotropic drugs or photosensitizing drugs * no other treatments for mood disorder during the study * diabetes or epilepsy * regular shift work

Keywords: seasonal affective disorder phototherapy circadian rhythms blue enriched light melanopsin low intensity
pulsed electro magnetic fields (pemf) in depression

Conditions: Depression, Unipolar

Summary: pemf (pulsed electro magnetic fields) therapy has been used to stimulate bone repair in non-union since the 1970s. this is an accepted use, which has been approved by the food and drug administration in the us. the mode of action of pemf is based on creating small electrical fields in tissue and thereby promoting healing. besides it has been shown that pemf enhance regeneration of nerve fibers exposed to a lesion for treatment of depression the pemf equipment, which are provided by the company re5 a/s, consists of a 220 v impulse generator that creates electrical impulses and an applicator which consists of an electrical cable connected to a helmet on which there are 7 electrical coils on the inside. in comparison with the rtms (transcranial magnetic stimulation) equipment, which uses stimuli approaching neuronal firing level, the pemf fields in human is very much lower.

applied to cells pemf have a stimulatory effect on intracellular tyrosine kinase activity, especially the src family. the src family upregulate nmdar (n-methyl-d-aspartate) subtype of glutamate receptor thereby gating the production of nmdar-dependent synaptic potentiation that are vital for processes that underlie physiological and pathological plasticity in the brain. dysregulation of fibroblast growth factor receptors in frontal cortical regions of the brain seem to be associated with depression. the fibroblast growth factors are highly dependent on the activity of the src family. for treatment of depression the pemf equipment, which are provided by the company re5 a/s, consists of a 220 v impulse generator that creates electrical impulses and an applicator which consists of an electrical cable connected to a helmet on which there are 7 electrical coils on the inside. in comparison with the rtms equipment, which uses stimuli approaching neuronal firing level, the pemf fields in human are very much lower. pemf treatment involves placing the treatment helmet on the head and connecting it to a power source (220 v), which leads to induction of a pulsating magnetic field. the treatment was given for 30 min once or twice daily for 8 weeks. participants are awake during these treatments and sit in a chair where they can read or eat. pilot data demonstrates that the treatment can give mild transient nausea. no other side effects have been observed.

Eligibility criteria:
inclusion criteria: * treatment resistant depression is defined as treatment with at least two antidepressants from different classes in an optimal dose and with sufficient duration (at least 8 weeks). * a score on hamd17 above 17. * antidepressant medication must not have been changed 4 weeks before inclusion. exclusion criteria: a ham-d17 item 3 at 2 or more (suicidal risk increased) a moderate manic condition (mas-m above 14) the participant must not be under some sort of restrictions pregnancy severe personality disorders psychotic mental disorders brain diseases

Keywords: depression, unipolar treatment resistant pemf
armeosenso - home therapy and assessment for patients with arm impairments based on wearable movement sensors

Conditions: Stroke; Spinal Cord Injury

Summary: stroke, spinal cord injury, rehabilitation, home therapy, upper limb, arm, virtual reality, interia sensor, * trial with medical device


Eligibility criteria:
inclusion criteria: * 18 years old * stroke or spinal cord injury in prehistory * motor deficits of the upper limb (s) * lifting the paretic arm against gravity possible and * minimum amount of movement in the horizontal plane of 20 x 20 cm * ability and willingness to participate in the study exclusion criteria: * severe aphasia * severe dementia * severe depression * relevant restriction of vision, which can not be compensated by aids (eg hemianopia)
a phase 1b study of qx1206 in t2dm patients with nafld

Conditions: Type 2 Diabetes Mellitus (T2DM); Non-Alcoholic Fatty Liver Disease (NAFLD)

Summary: this is an open label phase 1b trial of qx1206 in patients with t2dm and with nafld. laboratory tests and other measurements will be assessed prior to the first dose of study treatment and throughout the study to determine the recommended phase 2 dose. in addition, the preliminary effects of qx1206 on antidiabetic activity and other metabolic parameters will also be evaluated.


Eligibility criteria:
inclusion criteria: * signed written informed consent must be obtained and documented * 18 years of age and \< 65 years old * bmi ≥ 18 kg/m\^2 and \< 45 kg/m\^2 * t2dm diagnosed per 2021 american diabetes association criteria * diagnosis of nafld * for male or female patients of child producing potential: must agree to use contraception or take measures to avoid pregnancy during the study * women of child-bearing potential (wocbp) must have a negative pregnancy test * serum creatinine \< 1.5×uln or creatinine clearance ≥ 60 ml/min * participating patients must be able to comply with all study requirements and the study center must have appropriate means of ensuring protocol compliance for each participating patient exclusion criteria: * uncontrolled diabetes * patients with an active, serious medical disease that limit activities of daily living * patients with current, significant alcohol consumption or a history of significant alcohol consumption * patients with any of the following clinical laboratory abnormalities at screen and confirmed by a single repeat if deemed necessary: * fasting triglycerides \> 500 mg/dl * fasting direct ldl-c \> 190 mg/dl * ast \> 5.0 × upper limit of normal (uln) * alt \> 5.0 × uln * alkaline phosphatase (alp) ≥ 2 × uln * hba1c \> 10.5% * fasting plasma glucose (fpg) \> 240 mg/dl (13.3 mmol/l) * platelets count \< 140,000/mm\^3 * patient takes drugs historically associated with nafld and other known hepatotoxins * treatment with drugs (e.g., vitamin e \> 400 iu/day) or herbal supplements with potential anti-nafld effect
phase ii study for previously untreated subjects with non small cell lung cancer (nsclc) or small cell lung cancer (sclc)

Conditions: Lung Cancer; Small Cell Lung Cancer; Carcinoma, Non-Small-Cell Lung

Summary: the purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed lung cancer (stage iiib/iv nonsmall-cell lung cancer or extensive stage small-cell lung cancer \[sclc\]) * measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified world health organization criteria * eastern cooperative oncology group performance status of ≤1 at study entry * accessible for treatment and follow-up exclusion criteria: * brain metastases * malignant pleural effusion * autoimmune disease * motor neuropathy of autoimmune origin * sclc-related paraneoplastic syndromes * any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study) * prior systemic therapy for lung cancer. prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed. * grade 2 peripheral neuropathy (motor or sensory) * known hiv or hepatitis b or c infection * chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). however, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies. * inadequate hematologic function defined by an absolute neutrophil count \<1,500/mm\^3, a platelet count \<100,000/mm\^3, or hemoglobin level \<9 g/dl. * inadequate hepatic function defined by a total bilirubin level \>2.0 times the upper limit of normal (uln), or ≥2.5 times the uln if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the uln or ≥5 times the uln if liver metastases are present. * inadequate renal function defined by a serum creatinine level ≥2.5 times the uln * inadequate creatinine clearance defined as less than 50 ml/min.

Keywords: non small cell lung cancer (nsclc) small cell lung cancer (sclc)